FDA 510(k), K043401, SPECTRANETICS LLD CS, MODEL 518-039
FDA 510(k), K043401, SPECTRANETICS LLD CS, MODEL 518-039
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510(K) Number: K043401
Device Name: SPECTRANETICS LLD CS, MODEL 518-039
Manufacturer: SPECTRANETICS CORP.
Device Classification Name: stylet, catheter
Regulation Number: 870.1380
Classification Product Code: DRB
Date Received: 12/10/2004
Decision Date: 03/16/2005
Regulation Medical Specialty: Cardiovascular
Device Name: SPECTRANETICS LLD CS, MODEL 518-039
Manufacturer: SPECTRANETICS CORP.
Device Classification Name: stylet, catheter
Regulation Number: 870.1380
Classification Product Code: DRB
Date Received: 12/10/2004
Decision Date: 03/16/2005
Regulation Medical Specialty: Cardiovascular